Principles and practice of clinical research /
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| Edition: | 2nd ed. |
|---|---|
| Imprint: | Amsterdam ; Boston : Elsevier/Academic Press, c2007. |
| Description: | xvi, 430 p. : ill. ; 29 cm. |
| Language: | English |
| Subject: | |
| Format: | Print Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/6446969 |
Table of Contents:
- Preface
- Acknowledgements
- Historical Perspective and Introduction
- Part I. Ethical, Regulatory and Legal Issues Ethical Principles in Clinical Research
- Researching a Bioethical Question
- Integrity in Research: Individual and Institutional Responsibility
- Institutional Review Boards
- Data and Safety Monitoring Boards
- Data and Data Management in Clinical Trials
- Unanticipated Risk in Clinical Research
- The Regulation of Drugs and Biological Products by the Food and Drug Administration
- Legal Issues
- NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research
- Part II. Biostatistics and Epidemiology An Introduction to Biostatistics: Randomization, Hypothesis Testing and Sample Size
- Design and Conduct of Observational Studies and Clinical Trials
- Small Clinical Trials
- Large Clinical Trials Clinical Research Institutes
- Using Secondary Data in Statistical Analysis
- An Introduction to Survival Analysis
- Measures of Function and Health Related to Quality of Life
- Economic Analysis and Clinical Research
- Part III. Technology Transfer, Protocol Development and Funding
- Overview of Technology Development
- Technology Transfer
- Telemedicine Systems
- Animal Models of Human Disease
- Conducting and Evaluating Clinical Research on Complementary and Alternative Medicine
- Preparing Scientific Images for Publication and Display
- Writing a Clinical Protocol The Mechanics
- Navigating the Peer Review Process for Grants
